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WO1993000130A1 - Fil cardiaque a elements fixateurs retractibles - Google Patents

Fil cardiaque a elements fixateurs retractibles Download PDF

Info

Publication number
WO1993000130A1
WO1993000130A1 PCT/US1992/004998 US9204998W WO9300130A1 WO 1993000130 A1 WO1993000130 A1 WO 1993000130A1 US 9204998 W US9204998 W US 9204998W WO 9300130 A1 WO9300130 A1 WO 9300130A1
Authority
WO
WIPO (PCT)
Prior art keywords
fixation
lead
electrode
hole
chamber
Prior art date
Application number
PCT/US1992/004998
Other languages
English (en)
Inventor
Robert G. Dutcher
Brian M. Packard
Robert J. Scott
Original Assignee
Possis Medical, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Possis Medical, Inc. filed Critical Possis Medical, Inc.
Publication of WO1993000130A1 publication Critical patent/WO1993000130A1/fr

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/02Details
    • A61N1/04Electrodes
    • A61N1/05Electrodes for implantation or insertion into the body, e.g. heart electrode
    • A61N1/056Transvascular endocardial electrode systems
    • A61N1/057Anchoring means; Means for fixing the head inside the heart
    • A61N1/0573Anchoring means; Means for fixing the head inside the heart chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Definitions

  • the invention relates to cardiac leads having fixation members connectable to heart tissue for transmitting electric current to the heart and monitoring the electrical activity of the heart.
  • a cardiac pacing leads having tines that engage heart tissue and urge electrodes into contact with the endocardium in a direction parallel to the lead axis are disclosed by G.A. Bornzin in U.S. Patent No. 4,502,492 and J.E. Sluetz et al in U.S. Patent No. 4,662,382. Fibrotic growth of heart tissue around the electrode and tines prevent removal of the electrode from the heart without substantial damage to the heart.
  • a corkscrew connected to an electrode is disclosed by R.G. Baker in U.S. Patent Nos. 4,679,572 and 4,762,136 to provide active fexation of the electrode to the myocardium. The electrode must be rotated to attach and remove the electrode from the heart tissue.
  • a stylet is used to move the springs forwardly out of the sleeve into the heart tissue.
  • the stylet is also used to pull the springs back into the sleeve to retract the springs from the heart tissue.
  • the invention relates to a cardiac lead connectable to an implantable cardiac arrhythmia management device for transmitting electric current to the heart and/or sensing and monitoring « the electrical activity of the heart.
  • the implantable cardiac arrhythmia management device includes but is not limited to cardiac pacemakers and automatic implantable cardiac defibrillators (AICD).
  • the lead has an elongated flexible conductor enclosed within a sheath of nonelectrically conductive material to electrically connect the cardiac management device with an electrode having a distal surface adapted to be implanted in endocardium of the heart.
  • a tissue fixation assembly is operatively associated with the electrode to retain the electrode in contact with the endocardium of the heart.
  • the fixation assembly has a plurality of fixation members adapted to linearly move from a position within the electrode into the endocardium to retain the eletrode surface in engagement with the stimulatable heart tissue.
  • the fixation members are mounted on a moveable body located within a chamber in the electrode.
  • a stylet cooperates with the body to move the body and fixation members to a position wherein the fixation members project laterally and rearwardly from the electrode.
  • the extended fixation members retain the electrode in engagement with the endocardium.
  • the stylet is also used to retract the fixation members from the endocardum back into the electrode to permit removal of the electrode from the heart with a minimum of damage to the heart tissue.
  • Th electrode is an annular member of electrically conductive metal, such as titanum, platinum iridium or carbon, having an annular non-flat surface that cab be coated with platinum black particles which contact the heart tissue.
  • electrically conductive metal such as titanum, platinum iridium or carbon
  • Other tyes of coatings including but not limited to Pyrolitic carbon, titanium nitride, and the like can be used to enhance the electro-tissue interface between the ele ⁇ tode and heart tissue and to maximize electrical resistance between the electrode and the heart tissue.
  • Figure 1 is a diagrammatic view of a cardiac management system having the cardiac lead of the invention implanted in the right ventricle of a human heart;
  • Figure 2 is a side view of the electrode end of the lead showing the extended fixation members thereof ?
  • Figure 3 is an enlarged top view of the electrode end of the lead showing the retracted fixation members;
  • Figure 4 is an enlarged distal end view of the electrode end of Figure 3;
  • Figure 5 is an enlarged sectional view taken along line 5-5 of Figure 3;
  • Figure 6 is an enlarged sectional view taken along line 6-6 of Figure 3;
  • Figure 7 is an enlarged sectional view taken along line 7-7 of Figure 3;
  • Figure 8 is an enlarged sectional view taken along line 8-8 of Figure 3;
  • Figure 9 is an enlarged sectional view taken along line 9-9 of Figure 3;
  • Figure 10 is an enlarged sectional view taken along line 10-10 of Figure 6;
  • Figure 11 is a top view of the electrode end of the lead showing the extended fixation members
  • Figure 12 is an enlarged sectional view taken along the line 12-12 of Figure 11 ;
  • Figure 13 is a sectional view similar to Figure 12 with the stylet removed from the lead. DESCRIPTION OF PREFERRED EMBODIMENT
  • FIG. 1 there is shown a human heart indicated generally ⁇ at 10 provided with a cardiac arrhythmia management device 22, such as a pacemaker, pulse generator, and an implantable cardiac defibrillator having the removable lead indicated generally at 21 of the invention.
  • Heart 10 is shown as having a right atrium 11, a right ventricle 12 and a heart valve 13 for controlling the flow of blood from right atrium 11 into right ventricle 12.
  • a supply of blood flows in vein 14 having lumen 16 to right atrium 11.
  • the blood flows from the right ventricle 12 through a pulmonary artery 17 having a lumen 18 open to the right ventricle 12.
  • Lead 21 is connected to a cardiac arrhythmia management device 22 located within the human body outside of heart 10 for transmitting electric current to the heart and/or sensing and monitoring the electrical activity of the heart.
  • Lead 21 has a fixation assembly indicated generally at 23 partly within the trabecular carneae and/or apex of endocardium 19 in right ventricle 12.
  • fixation assembly 23 has an elongated cylindrical body 24 of electrically conductive material such as metal and like conductors.
  • Body 24 has a longitudinal chamber 26 closed at its distal or forward end with a head disc 27.
  • Body 24 has an annular form or lip 28 turned inwardly over disc 27 to retain disc 27 on body 24. Lip 28 is also turned over insert 32 to retain insert 32 on the forward end of body 24.
  • form 28 has an annular arcuate outer surface that is coated with platinum black particles 29.
  • Form 28 has a plurality of circumferentially spaced holes 30 open to the outer surface thereof for additional ingrowth of tissue to assist in anchoring form 28 to endocardium 19.
  • the platinum black particles 29 have a microporous structure which allows the distal end of the electrode to be located in close proximity to the stimulatable heart tissue. This increases the current density to the tissue and thereby lowers stimulation thresholds.
  • the microsurface porous black particles 29 results in the growth of a thinner fibrotic capsule surrounding the electrode and fixation assembly.
  • Other types of electrical conductive materials such as Pyrolitic carbon and titanium nitride, can be secured to the annular outer surface of form 28.
  • Insert 32 has a convex exterior surface 33 that is coextensive with the outer surface of form 28 coated with platinum black particles 29.
  • the outer surface 22 of insert 32 can have other configurations, such as flat, concave or the like.
  • Insert 32 is a bio-compatible plastic, such as silicone rubber, synthetic fabric including but not limited to woven polyester. Teflon and the like.
  • a jacket sleeve 34 of electrical insulating material such as bio-compatible plastic, ceramic or silicone rubber, surrounds body 24 so that only the platinum black particles 29 make electrical contact with the endocardium.
  • Body 24 has a transverse neck 36 having a central hole 37 open to chamber 26.
  • a tubular end 38 joined to neck 36 is connected to an electrical conductor 39 shown as a wire coil.
  • a retainer sleeve 41 positioned within tubular end 38 holds the distal end of conductor 39 in electrical contact with tubular end 38.
  • Retainer 41 has a central hole or passage 42 in alignment with hole 37 and neck 36.
  • Conductor 39 is located within a connector 43 joined to an elongated flexible tubular sheath 44.
  • Connector 43 is a tubular electrical insulator, such as plastic, silicone rubber and the like.
  • Sheath 44 is an elongated tube of biocompatible and non-electrical conductive material that extends from electrode and fixation assembly 23 to cardiac arrhythmia management device 22.
  • Coil 39 is located within the longitudinal passage 46 of sheath 44 which leads to cardiac arrhythmia nanagement device 22.
  • Fixation assembly 23 has a plurality of fixation members having elongated wire-like structures that are moveable into the heart tissue to retain form 28 of the electrode in intimate contact with the heart tissue and retractable into body 24 to allow the lead to be removed from the heart.
  • fixation members 47, 48, 49, and 50 are located in chamber 26.
  • Fixation assembly 23 has four fixation members 47-50.
  • Fixation members 47-50 are metal rods coated with non-electrical conductive material, such as bio-compatible plastic.
  • fixation members 47 and 50 are ends of a U-shaped flexible wire or rod 51 embedded within a layer or coat 52 of bio-compatible plastic material. The entire wire 51 is covered with coat 52 so that the fixation members 47 and 50 are non-electrically conductive.
  • Fixation members 48 and 49 have the same shape and structure as fixation members 47 and 50.
  • fixation members 47-50 are positioned on a tubular member or ring 53 of medical grade plastic, such as polycarbonate.
  • Ring 53 has a first pair of grooves 54A and 54B accommodating fixation members 47 and 50 and a second pair of grooves 55A and 55B accommodating fixation members 48 and 49.
  • Grooves 54A, 54B, 55A, and 55B circumferentially space fixation members 47-50 around ring 53.
  • ring 53 has additional open grooves to relieve any hydraulic effects due to fluid in chamber 26.
  • the center of ring 53 has a circular hole 56.
  • annular sleeve 57 surrounds ring 53 to hold fixation members 47-50 in grooves 54A, 54B, 55A, and 55B.
  • sleeve 57 has a metal core 58 coated with bio-compatible plastic material 59.
  • the distal end 61 of sleeve 57 is turned inwardly over a disk 62 located in front of ring 53.
  • the opposite end 72 of sleeve 57 is turned inwardly over ring 53 to clamp fixation members 47-50 onto ring 53.
  • Electrode and fixation assembly 23 can be provided with additional fixation members which are extendable into the endocardium and retractable therefrom.
  • additional fixation members which are extendable into the endocardium and retractable therefrom.
  • fixation assembly canhave one pair of fixation members. The number of fixation members can vary.
  • fixation members 47-50 when in retracted positions have outer ends located in body 24 adjacent neck 36.
  • Sleeve 34 may have openings to allow fixation members 47-50 to be moved to their extended positions as shown in Figures 1, 2, 11, 12 and 13.
  • the openings in sleeve 34 can be formed by the fixation members 47-50 as they are moved to the extended position. Openings 63 are inclined rewardly to guide fixation members 47-50 outwardly and rearwardly from body 24.
  • Neck 36 has beveled outer edges 64 that serve as ramps or guiding surfaces for fixation members 47-50 during movement thereof to the extended positions.
  • fixation members 47-50 project rearwardly at an angle of about 45 degrees from the longitudinal axis of the electrode and fixation assembly 23. Other angular orientations of fixation members 47-50 can be used.
  • stylet 65 is used to move fixation members 47-50 between their retracted positions, as shown in Figure 9, and their extended positions, as shown in Figure 12.
  • stylet 65 has an elongated body or wire 66 terminating in a spherical head 67 at the distal end thereof.
  • a short tapered neck 68 having a diameter less than the diameter of hole 56 and ring 53 joins head 67 to wire 66.
  • Head 67 has a diameter larger than the diameter of hole 56.
  • Head 67 has a snap fit relative to ring 53 whereby head 67 can be forced through hole 56 and pulled out of hole 56 so that stylet 64 can be removed from pacing lead 21.
  • stylet 64 is located in passage 46 of sheath 44 and extends through hole 42 in retainer 41 , hole 37 in neck 36, through chamber 26 with head 67 located in a space 69 between ring 53 and disk 62.
  • Fixation members 47-50 are in their retracted positions within body 24 whereby the electrode and fixator assembly 23 has a generally outside cylindrical configuration which permits the lead to be implanted in and removed from the heart with a minimum of damage to the heart tissue.
  • Lead 21 is implanted into the heart of right ventricle 12 in engagement with the endocardium 19 at the base of ventrical 12 as shown in Figure 1 , by threading the lead through lumen 16 of vein 14, atrium 11, and ventricle 12.
  • Stylet 65 is then pulled as indicated by the arrow 71 in Figure 11 and 12 by the physician while sheath 44 and the remainder of the electrode and fixation assembly 23 is held in position. Ring 53 along with fixation members 47-50 are moved to their extended positions as shown in Figure 11 with fixation members 47-50 projecting into the heart tissue. The rearward inclination of fixation members 47-50 retain electrode surface 29 in firm and intimate contact with the endocardium. Stylet 65 moves ring 53 rearwardly to a position adjacent neck 36. Continued pulling force on stylet 65 snaps head 67 from ring 53 so that the entire stylet 65 is removed from lead 21. Figure 13 shows the electrode and fixation assembly 23 with fixation members 47-50 in their extended positions with stylet 65 removed from pacing lead 21.
  • Stylet 65 is also used to retract fixation members 47-50 from the endocardium.
  • Wire 66 and head 67 is threaded through passage 46 of sheath 44, hole 42 in retainer 41 , and hole 37 in neck 36. Head 67 is forced through the hole 56 in ring 53 into engagement with disk 62. Further inward movement of stylet 65 into pacing lead forces ring 53 and fixation members 47-50 to move forwardly whereby fixation members 47-50 move into chamber 26 of body 24 as shown in Figure 9.
  • Fixation members 47-50 retract linearly in the direction of their length from the heart tissue thereby minimizing injury to the heart tissue.
  • the outer surface of electrode and fixation assembly 23 is cylindrical and smooth. This permits the entire lead 21 to be removed from the heart and body of the person.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Radiology & Medical Imaging (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Electrotherapy Devices (AREA)

Abstract

Un fil cardiaque (21) comporte une électrode (28) ainsi qu'un ensemble de fixation (23) comprenant une pluralité d'éléments de fixation (47, 48, 49, 50) que l'on peut déplacer dans des positions déployées dans des tissus cardiaques afin de maintenir l'électrode (28) en contact intime avec lesdits tissus cardiaques. On utilise une sonde allongée (65) afin de déplacer les éléments de fixation (47, 48, 49, 50) jusque dans leur position déployée dans les tissus cardiaques, et afin de rétracter les éléments de fixation dans l'ensemble de fixation (23) afin de permettre le retrait du fil (21) du coeur et du corps d'une personne.
PCT/US1992/004998 1991-06-20 1992-06-15 Fil cardiaque a elements fixateurs retractibles WO1993000130A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US718,377 1991-06-20
US07/718,377 US5179962A (en) 1991-06-20 1991-06-20 Cardiac lead with retractible fixators

Publications (1)

Publication Number Publication Date
WO1993000130A1 true WO1993000130A1 (fr) 1993-01-07

Family

ID=24885884

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1992/004998 WO1993000130A1 (fr) 1991-06-20 1992-06-15 Fil cardiaque a elements fixateurs retractibles

Country Status (3)

Country Link
US (1) US5179962A (fr)
AU (1) AU2238592A (fr)
WO (1) WO1993000130A1 (fr)

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EP0620024A1 (fr) * 1993-02-12 1994-10-19 Pacesetter AB Dispositif d'électrodes
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DE102019111021A1 (de) * 2019-04-29 2020-10-29 Biotronik Se & Co. Kg Aus- und zurückfahrbares Fixierelement zur Elektrodenfixierung in Blutgefäßen

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